Universal Neoprene Chinstrap

Basic Information

• Brand Name: Universal Neoprene Chinstrap
• Primary DI: 00848530080013
• Version / Model: CS001
• Catalog Number: CS001
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Labeler DUNS: 141668116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-31
• Public Version: 1
• Public Version Date: 2018-08-31
• Public Version Status: New
• Public Device Record Key: 9ef424e3-289c-46e8-9850-d064b791267f

Device Description

Universal Neoprene Chinstrap. Can be used with any nasal mask or nasal pillows, one size fits most.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTK	Strap, Head, Gas Mask	Anesthesiology	868.5560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31254	Anaesthesia mask strap, reusable	A band of material designed to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and often affixed to a special stabilizing device (e.g., with hooks) located on the gas connection port of the mask. It is typically used for anaesthesia of long duration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848530080013	GS1
Package	10848530080010	GS1		250	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]